Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.

NCT05134935 | Completed

• 1 other identifier: NISDO
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is: \- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy? The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Axial length growth of the eye

  Length in mm is measured 18 months after therapy

  18 months

Secondary Outcomes (1)

• Overall eye length growth, defined as the sum of axial length and choroidal thickness

  18 months

Other Outcomes (3)

• Choroidal thickness

  During 18 months of therapy

• Pupil size

  6 months

• Vision related quality of life using the questionnaire PREP2

  Prior to and 9 months after treatment initiation

Study Arms (2)

OKL

ACTIVE COMPARATOR

Device: Orthokerathology lenses (OKL)

DIMS

EXPERIMENTAL

Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles

Interventions

Defocus Incorporated Multiple Segment (DIMS) Spectacles DEVICE

18 months of therapy.

Also known as: Defocus (DIMS) Spectacles

DIMS

Orthokerathology lenses (OKL) DEVICE

18 months of therapy.

Also known as: Night lenses

OKL

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
• Myopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
• Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error.
• Best corrected visual acuity at age 6 to 12 years (inclusive): 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters)

You may not qualify if:

• Manifest or intermittent squint.
• Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis and keratoconjunctivitis sicca.
• Previous eye surgery.
• Chronic eye disease demanding daily use of eye drops.
• Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses).
• Previous myopia control treatment.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

The Ophthalmic department, Vejle Hospital

Vejle, Southern Denmark, 7100, Denmark

Location

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Lou-Ann Andersen

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: June 29, 2022
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)